Isosorbide Mononitrate Tablet, Extended Release
NDC Package 0904-6449-61

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Isosorbide Mononitrate tablets is isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease). This formulation utilizes a tablet, extended release delivery system. Marketed by Major Pharmaceuticals, this product is identified by NDC 0904-6449 and is authorized under FDA application ANDA200270.

Identification & Billing

NDC Package Code
0904-6449-61
Package Description
100 BLISTER PACK in 1 CARTON / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
0904-6449
11-Digit Billing Format
00904644961
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 317110 - isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet
  • RxCUI: 317110 - 24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet
  • RxCUI: 317110 - isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 353538 - isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet
  • RxCUI: 353538 - 24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Isosorbide Mononitrate
Non-Proprietary Name
Isosorbide Mononitrate
Substance Name
Isosorbide Mononitrate
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ISOSORBIDE MONONITRATE 30 mg/1
Pharmacologic Class
Usage Information
Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease). This medication belongs to a class of drugs known as nitrates. It works by relaxing and widening blood vessels so blood can flow more easily to the heart. This medication will not relieve chest pain once it occurs. Also, it is not intended to be taken just before physical activities (such as exercise or sexual intercourse) to prevent chest pain. Other medications may be prescribed by your doctor for these conditions. Consult your doctor for more details.

Regulatory & Marketing

Labeler Name
Major Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA200270
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-05-2015
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0904-6449-61 identifies a specific commercial package of 100 blister pack in 1 carton / 1 tablet, extended release in 1 blister pack of Isosorbide Mononitrate, a human prescription drug labeled by Major Pharmaceuticals. This tablet, extended release is formulated for oral use and contains isosorbide mononitrate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Major Pharmaceuticals on January 05, 2015. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease). This medication belongs to a class of drugs known as nitrates. It works by relaxing and widening blood vessels so blood can flow more easily to the heart. This medication will not relieve chest pain once it occurs. Also, it is not intended to be taken just before physical activities (such as exercise or sexual intercourse) to prevent chest pain. Other medications may be prescribed by your doctor for these conditions. Consult your doctor for more details.

How is this Major Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904644961. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0904-6449-61
11-Digit CMS (5-4-2)
00904-6449-61

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.